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# VP of Regulatory Affairs – Miami, FL


 
Vice President (VP) of Regulatory Affairs – Medical Device Industry
Are you an expert in navigating the complex landscape of medical device regulations? A leading medical device company in Miami, FL is seeking a strategic and experienced Vice President of Regulatory Affairs to oversee and lead global regulatory strategy and compliance. This is a unique opportunity to play a critical leadership role in ensuring products meet all regulatory requirements, from development through commercialization. If you are a results-driven regulatory leader who thrives in a highly technical and innovation-focused environment, this position is for you.
Shape Regulatory Strategy for a Leading Medical Device Company in Miami
Join a well-established and forward-thinking medical device organization as its VP of Regulatory Affairs. Based in Miami, FL, this executive role is ideal for a seasoned professional with in-depth knowledge of FDA, EU MDR, and global regulatory frameworks. The successful candidate will lead cross-functional regulatory initiatives, manage regulatory submissions, and maintain compliance throughout the product lifecycle. If you’re passionate about advancing healthcare technology through regulatory excellence, this is your chance to make a significant impact.
Key Responsibilities of the VP of Regulatory Affairs – Medical Device
Global Regulatory Strategy:Develop and execute comprehensive global regulatory strategies for new and existing medical device products. Ensure alignment with corporate goals and evolving regulatory requirements across all markets, including FDA, EU MDR, and other international agencies.
Regulatory Submissions & Approvals:Lead the preparation, submission, and maintenance of regulatory dossiers, including 510(k), PMA, CE marking, and international registrations. Collaborate with cross-functional teams to gather documentation and ensure timely approvals.
Regulatory Compliance & Governance:Ensure ongoing compliance with applicable regulations, standards, and guidance documents. Maintain up-to-date knowledge of changes in the regulatory landscape and implement policies and processes to support continuous compliance.
Cross-Functional Collaboration:Partner with R&D, Clinical, Quality, and Marketing teams to ensure regulatory considerations are integrated throughout the product development lifecycle. Serve as the regulatory subject matter expert in product planning and risk assessments.
Team Development & Leadership:Lead, mentor, and grow a high-performing regulatory affairs team. Provide direction, coaching, and development opportunities while fostering a culture of accountability, excellence, and continuous improvement.
Risk Management & Quality Alignment:Work closely with Quality Assurance to evaluate regulatory risks and develop mitigation strategies. Support internal and external audits, inspections, and post-market surveillance efforts.
Regulatory Intelligence & Advocacy:Monitor global regulatory trends and emerging requirements. Represent the company in regulatory discussions with health authorities, industry groups, and standards organizations.
Labeling & Promotional Review:Oversee regulatory review and approval of product labeling, advertising, and promotional materials to ensure accuracy, compliance, and alignment with product claims.
Product Lifecycle Management:Support regulatory activities across the full product lifecycle, including design changes, line extensions, and market withdrawals. Maintain regulatory documentation and ensure timely reporting of changes.
Ethical Compliance & Documentation:Ensure ethical standards in all regulatory interactions and maintain clear, accurate, and complete records to support inspections, audits, and corporate governance.
What the Client is Looking for in You
As the Vice President (VP) of Regulatory Affairs – Medical Device, the client is seeking a highly experienced regulatory leader with deep expertise in medical device compliance, global regulatory strategy, and cross-functional leadership. You should be a detail-oriented, strategic thinker with a strong command of FDA, EU MDR, and international regulatory landscapes—capable of ensuring product approval and market access while driving innovation and operational efficiency.
Extensive Experience in Medical Device Regulatory Affairs
The ideal candidate has a proven track record in regulatory affairs within the medical device industry, particularly with Class II and Class III devices. You should have experience leading successful submissions such as 510(k), PMA, CE Marking, and international registrations, and managing global regulatory teams through complex approval processes.
Strategic Vision and Global Regulatory Insight
The client is looking for a visionary leader who can shape and execute global regulatory strategies aligned with company growth objectives. Your ability to assess regulatory risks, interpret new guidelines, and proactively adapt to changes in global health authority requirements will be key to success in this role.
Strong Leadership and Cross-Functional Influence
You should be an empowering leader capable of building, mentoring, and inspiring high-performing regulatory teams. The client values your ability to collaborate effectively with internal stakeholders in R&D, Quality, Clinical, and Marketing, and to provide clear regulatory direction throughout the product lifecycle.
Deep Understanding of FDA, EU MDR, and Global Regulations
A comprehensive understanding of medical device regulations, including FDA 21 CFR, EU Medical Device Regulation (MDR), ISO standards, and global compliance requirements, is essential. You must demonstrate the ability to lead audits, ensure ongoing compliance, and serve as the company’s regulatory liaison with health authorities.
Strong Analytical and Communication Skills
The client seeks a data-driven leader who can interpret complex regulations and communicate them clearly to both technical and non-technical stakeholders. Your ability to deliver concise regulatory strategies, manage documentation, and provide insights for executive decision-making is highly valued.
Ethical Integrity and Compliance Leadership
You must uphold the highest standards of integrity, compliance, and ethical conduct. The client values your ability to navigate regulatory challenges while ensuring quality, safety, and legal compliance across all markets.
Execution Excellence and Detail Orientation
This role requires precision and accountability. You should excel at managing multiple regulatory projects, maintaining documentation accuracy, meeting deadlines, and navigating high-stakes submission processes under pressure.
FAQs About the Role – Vice President (VP) of Regulatory Affairs – Medical Device
1. What are the key responsibilities of the VP of Regulatory Affairs?As the VP of Regulatory Affairs, you will lead the development and execution of global regulatory strategies to ensure timely product approvals and market access. Your responsibilities include overseeing submissions such as 510(k), PMA, and CE Marking, managing compliance with FDA, EU MDR, and international regulations, guiding cross-functional teams, and serving as the primary liaison with regulatory agencies.
2. What qualifications and experience are required for this position?The ideal candidate should have 10+ years of regulatory affairs experience in the medical device industry, including leadership of global regulatory teams and successful management of high-risk (Class II/III) device submissions. A bachelor’s degree in life sciences, engineering, or a related field is required; an advanced degree (e.g., MS, PhD, or RAC certification) is preferred.
3. What regulatory expertise is expected from candidates?You must demonstrate deep knowledge of FDA regulations (21 CFR Part 820), EU Medical Device Regulation (MDR), ISO 13485, and other global compliance standards. Experience in navigating audits, resolving regulatory challenges, and managing post-market surveillance and labeling requirements is essential.
4. What leadership qualities are essential for this role?The client seeks a proactive, detail-oriented leader with strong communication skills and the ability to influence cross-functional teams. You should possess strategic thinking, high ethical standards, regulatory foresight, and the capability to mentor and grow a high-performing regulatory department.
5. What are the biggest challenges in this role?Challenges include managing complex and evolving global regulatory landscapes, ensuring timely product launches, maintaining compliance across multiple jurisdictions, and adapting to new regulatory requirements. The role demands a balance of strategic oversight and operational precision under tight timelines.
6. How will this role contribute to the company’s success?The VP of Regulatory Affairs plays a critical role in ensuring the company’s medical devices reach the market efficiently and compliantly. Your leadership will impact regulatory readiness, reduce time to market, mitigate compliance risks, and strengthen relationships with regulatory authorities—ultimately supporting business growth and innovation.
7. What is the company culture like?The company promotes a culture of innovation, collaboration, and integrity. It values leaders who foster transparency, compliance excellence, and team development. The work environment is dynamic and mission-driven, with a focus on improving patient outcomes through regulatory rigor and high-quality medical technology.
What Remuneration Can You Expect from This Job?
As the Vice President (VP) of Regulatory Affairs in the Medical Device industry based in Miami, FL, you can expect a highly competitive and comprehensive compensation package reflective of your expertise, leadership responsibilities, and the critical role you play in global regulatory strategy. The remuneration typically includes:
1. Base Salary
The annual base salary for a VP of Regulatory Affairs in the medical device sector ranges between $220,000 and $350,000, depending on the company’s size, product portfolio, and regulatory complexity. Executive-level candidates with deep FDA and EU MDR experience may command salaries at the higher end of the spectrum.
2. Performance-Based Bonuses
Most compensation packages include annual performance bonuses, typically ranging from 20% to 40% of the base salary. These bonuses are linked to successful product approvals, regulatory milestones, audit outcomes, compliance achievements, and overall team performance.
3. Long-Term Incentives & Equity
To align executive interests with long-term company performance, many employers offer equity compensation, such as stock options, RSUs (Restricted Stock Units), or performance-based shares. These incentives are particularly common in publicly traded or growth-stage companies and can significantly increase total earnings over time.
4. Executive Benefits Package
You will be eligible for a suite of executive-level benefits, which may include:


Comprehensive health, dental, and vision insurance


401(k) with generous company matching or executive retirement plans


Disability and life insurance


Executive wellness programs


Expense accounts for professional development, conferences, and travel


Paid time off (PTO), sick leave, and paid holidays


5. Signing Bonus & Relocation Assistance
For highly qualified candidates, companies may offer a signing bonus—typically ranging from $25,000 to $100,000—as well as relocation assistance for candidates moving to the Miami area. These incentives are structured to support a smooth transition into the new role.
Total Compensation Potential
When combining base salary, bonuses, equity, and incentives, the total annual compensation for a VP of Regulatory Affairs can exceed $400,000 to $600,000+, depending on company performance, regulatory milestones, and equity value. This role offers a lucrative package commensurate with its strategic and operational importance to the business.
How to Apply
If you are a seasoned regulatory affairs executive with a passion for innovation and compliance in the Medical Device industry, we encourage you to apply for the Vice President (VP) of Regulatory Affairs position based in Miami, FL. This is a strategic leadership opportunity to drive global regulatory strategies, lead submissions, ensure regulatory compliance, and play a critical role in bringing life-changing medical technologies to market.
To apply, please submit your resume and a cover letter highlighting your expertise in:


Global regulatory affairs (including FDA, EU MDR, Health Canada, etc.)


Pre- and post-market submissions


Leading cross-functional regulatory teams


Navigating complex product approval processes


Building regulatory infrastructure and strategy for device innovation and commercialization


Showcase your ability to lead in high-growth, fast-paced environments while maintaining the highest standards of regulatory excellence and collaboration with product development, clinical, and quality teams.
This is your chance to join a company at the forefront of medical innovation and regulatory leadership. Apply today to advance your executive career as a VP of Regulatory Affairs – Medical Device in Miami, FL.
For more information or to explore additional leadership roles in medtech, visit our Medical Device Executive Search page.
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